See Supplemental Patient Information
- Therapy should be administered only under the supervision of a physician experienced in cancer chemotherapy and where adequate medical facilities are available to manage complications [US Black Box Warning]
- Both early and late forms of diarrhea, possibly severe, may occur with the therapy. If severe diarrhea occurs, interrupt irinotecan treatment and reduce future doses [US Black Box Warning]
- Temporarily suspend irinotecan during a cycle of therapy if neutropenic fever occurs or if the ANC <1000/mm3; resume reduced dose once ANC
1000/mm3 - Do not use in combination with the "Mayo Clinic" regimen of 5-FU/LV because reports of increased toxicity, including toxic deaths, have been reported with such use
- Carefully monitor patients with diarrhea; give fluid and electrolyte replacement if dehydration occurs and give antibiotics if ileus, fever, or severe neutropenia develops
- Deaths have been reported in patients receiving irinotecan due to sepsis following severe neutropenia. Therapy may cause severe myelosuppression
- There is an increased risk for neutropenia following initiation of irinotecan treatment in patients homozygous for the UGT1A1*28 allele
- Hypersensitivity reactions such as severe anaphylactic or anaphylactoid reactions have been observed
- Therapy may cause colitis complicated by ulceration, bleeding, ileus, and infection. Institute prompt antibiotic support in patients experiencing ileus
- Rare instances of renal impairment and acute renal failure have been reported in patients who became volume depleted from severe vomiting and/or diarrhea
- Thromboembolic events have been observed in patients receiving irinotecan-containing regimens
- Serious and fatal interstitial pulmonary disease (IPD)-like events have been reported during irinotecan therapy; if this occurs, discontinue the irinotecan and other co-prescribed chemotherapeutic agents and institute appropriate treatment
- IV administration may cause extravasation and the infusion site inflammation. Flushing of the site with sterile water and applications of ice are recommended if extravasation occurs
- Patients should receive premedication with antiemetic agents because irinotecan has emetigenic effects
- Administer 0.25-1 mg IV/SC atropine if patients experience rhinitis, increased salivation, miosis, lacrimation, diaphoresis, flushing, abdominal cramping, or diarrhea with the irinotecan therapy
- Serious or life-threatening infections may result with the administration of live or live-attenuated vaccines in patients immunocompromised by irinotecan; avoid vaccination with a live vaccine in this population
Cautions: Use cautiously in
- Renal impairment
- Severe hepatic impairment
- Recent abdominal or pelvic XRT
- Hyperbilirubinemia
- Decreased UGT1A1 activity
- Gilbert syndrome
- History of colitis
- History of thromboembolism
- Elderly patients
Supplemental Patient Information
- Instruct patients to promptly contact their physicians should any diarrhea for the first time during treatment, symptoms of dehydration, nausea or vomiting, black or blood stools, inability to get diarrhea under control within 24 hrs, or fever or evidence of infection develop
- Caution patients to refrain from driving or operating a machinery due to the potential for dizziness or visual disturbances, which may occur within 24 hrs following irinotecan administration
- Alert patients to the possibility of alopecia
Pregnancy Category:D
Breastfeeding: Unsafe. Manufacturer recommends discontinuation of nursing during irinotecan therapy.
